It is believed that chronic prostatitis is one of the most common reasons why men visit urologists, even being characterized as the condition responsible for more outpatient visits than benign prostatic hypelplasia (“BPH”) or prostate cancer. At least one report states that 35–50% of men will be affected by prostatitis at some time in their life. The treatments conventionally used to treat this condition have been generally problematic; most of the treatments have provided little hope that the condition could be predictably treated in a manner which could successfully alleviate the pain experienced by a large percentage of these individuals. Indeed, prostatitis has been termed “a waste basket of clinical ignorance” because of the lack of knowledge about the basic epidemiology of the disease and also the diagnosis and treatments available for same. See McNaughton Collins et al., How Common is Prostatitis? A National Survey of Physician Visits, Jnl. Of Urology, Vol. 159, pp. 1224–1228 (April 1998).
Unlike BPH, which occurs primarily in older men, prostatitis can occur in both younger (men in age groups of 18–50 (or younger)) and older men (over the age of 50), with the median reported patient age at about 40 years of age. See How Common is Prostatitis? supra at p. 1228. It is thought to be the most common urologic diagnosis for men less than 50 years of age.
There are several classifications or types of prostatitis, each of which may have different characteristics, manifestations, symptoms, or treatment protocols: Type I: acute bacterial prostatitis; Type II: chronic bacterial prostatitis; Type III: chronic (non-bacterial) prostatitis and/or chronic pelvic pain syndrome (CPPS); and Type IV: asymptomatic inflammatory prostatitis. See Nickel et al., Research Guidelines for Chronic Prostatitis: Consensus Report From the First National Institutes of Health International Prostatitis Collaborative Network, Urology, 54(2), pp. 229–233, 230 (1999).
The Type III prostatitis class (non-bacterial chronic prostatitis) is generally associated with urogenital pain in the absence of uropathogenic bacteria detected by standard microbiological methodology. See Nickel et al., Research Guidelines for Chronic, supra, p. 230. The Type III may be further defined as IIIA (inflammatory) or IIIB (noninflammatory). The IIIA inflammatory type prostatitis can be identified based on the presence of leulcocytes in expressed prostatic secretions or fluids, post prostatic massage urine, or semen, while the IIIB non-inflammatory type can be identified based on the absence of detectable leukocytes in similar specimens. This type of prostatitis may also be associated with variable voiding, sexual dysfunction, and/or psychologic alterations (particularly depression).
Only a small number of reported prostatitis cases are believed to be of the Type I or acute bacterial type, while the remaining classes of chronic prostatitis may affect an estimated 30 million men in the United States. In any event, as noted above, one of the primary symptoms of prostatitis is a chronic urogenital pain which can negatively impact the quality of life of individuals experiencing this condition. This pain may occur with urination, ejaculation, or in other urogential manifestations. It has been stated that the impact on the quality of life may be similar to those patients suffering unstable angina, a recent myocardial infarct, or active Crohn's disease. As such, chronic prostatitis is a major health care issue. See J. Curtis Nickel, Prostatitis: Myth and Realities, Urology 51 (3), pp. 362–366 (1998).
To assess the severity of prostatitis symptoms and responsiveness to certain therapies, certain standardized assessment protocols can be used. For example, the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) uses a survey with nine questions and answers having assigned numerical weights so that a subject rate his degree of pain, the degree of symptoms, and his quality of life relating thereto. In this survey, the total of items 1a, 1b, 1c, 1d, 2a, 2b, 3, and 4 relates to the degree of the subject's pain, the total of items 5 and 6 relates to the degree of the urinary symptoms that the subject is experiencing, and the total of items 7, 8, and 9 relates to the subject's quality of life. Similarly, other scores, indexes and surveys can be used to diagnose or assess treatment efficacy, such as an International Prostate Symptom Score (IPSS) system of seven questions. However, the NIH-CPSI was nominated as the standard of choice for clinical trials occurring after 1999, as presented at the Annual Meeting of the American Urological Association in Dallas, Tex., in May of 1999.
It is estimated that, conventionally, physicians cannot offer about 95% of their patients who do not have a definite microbiologic etiology an evidence-based therapeutic plan. See Nickel et al., Research Guidelines for Chronic Prostatitis, supra, p. 229.
Various treatment protocols have been used to attempt to treat prostatitis. While Type I may be managed successfully with wide spectrum antibiotics, patients having Type II and III prostatitis have had lesser degrees of response success when treated with antibiotics. Other treatment regimes include other drugs such as alpha-blocker therapy (for obstructive voiding), and anti-inflammatory agents. In addition, or alternatively, the physician may suggest lifestyle changes such as diet (such as the reduction of the intake of caffeine), exercise, sexual activity, and/or supportive psychotherapy or “coping mechanisms”.
Other treatment protocols suggested include repetitive prostate massage via the rectum as performed by the patient or assisted by another (such as 2–3 times per week), phytotherapy, transurethral microwave thermo (heat) therapy, or even radical transurethral resection of the prostate, radical open prostatectomy, and bladder neck surgery. See Prostatitis: Myths and Realities, supra, p. 365; and Special Report on Prostatitis Initiatives and Future Research; Rev. Urol. 2000; 2(3):158–166 (Summer 2000) (presenting, at page 9, various recommended therapies for research in the highlights of the second International Prostatitis Collaborative Network Meeting, November 3–5, Bethesda, Md.). Unfortunately, as succinctly stated by one author, “[t] he reality of prostatitis treatment is that it results in a dismal cure rate and an unacceptably high relapse or recurrence rate.” Id.
As noted above, one type of therapy proposed to treat this condition is transurethral microwave thermo (heat) therapy. See, e.g., Choi et al., Clinical experience with transurethral microwave thermotherapy for chronic non-bacterial prostatitis and prostatodynia, Jnl. of Endourology, Vol. 8, pp. 61–64 (1994); Montorsi et al., Is there a role for transrectal microwave hyperthermia of the prostate in the treatment of a bacterial prostatitis and prostatodynia? Prostate, Vol. 22, pp. 139–146, (1993); Nickel et al., Transurethral microwave thermotherapy of nonbacterial prostatitis and prostadynia; initial experience, Urology, Vol. 44, pp. 458–460 (1994); and Nickel et al., Transurethral microwave thermotherapy for nonbacterial prostatitis: a randomized double-blind sham controlled study using new prostatitis specific assessment questionnaires, Jnl. of Urology, Vol. 155, pp. 1950–1955 (1996). The transurethral microwave therapy may be delivered such that the prostatic tissue is non-uniformly exposed to the heat from the microwave energy. In addition, the use of microwave energy in the prostate may also unduly expose non-targeted tissue to the microwave energy. Further, some of the proposed microwave treatment regimes use numerous treatments, such as six treatments over a 6-week period, and success with such treatment remains uncertain. Others have proposed a transurethral needle ablation (TUNA) of the prostate for treating non-bacterial chronic prostatitis. See e.g., Giannakopoulos, et al., Chronic Nonbacterial Prostatitis and TUNA®: 5 Years Clinical Experience, European Eurology, 37 Supplement, p. 46 (March 2000). Still others have evaluated RF treatments. See Nickel, et al., Transurethral radio frequency hot balloon thermal therapy in chronic nonbacterial prostatitis, Techniques in Urology, Vol. 4, pp. 128–130 (1998).
In view of the above, there remains a need to provide improved and/or alternative treatments for chronic prostatitis.